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CompletedNCT03407235LapACQUpdated Oct 15, 2018

Simulating Laparoscopy With an Eye Patch

An interventional study of Computerized Laparoscopic Trainer and Box trainer with eye patch in Laparoscopic Training, sponsored by University of Nottingham. Completed at 2 sites in United Kingdom. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-15.

Sponsored by University of Nottingham · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study summary

Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.

Read the detailed description

Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic training exercises on both the laparoscopic computerized trainer and on a simple box trainer with an eye patch.

Novices will be allowed to familiarize themselves with the laparoscopic instruments and will be shown short video clips to demonstrate tasks.

They then will have five minutes to complete each of the four tasks. They will return 1-2 weeks later to complete the same process on the alternative training method.

All participants will complete the tasks on both the computerized lap simulator and the box trainer.

02

Conditions studied

  • Laparoscopic Training
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Laparoscopic Novices
  • 20-40 years
  • All genders

Exclusion criteria

Exclusion Criteria:

  • Previous laparoscopic surgical experience
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Laparoscopic Novices

    Four laparoscopic task will be undertaken on a computerized laparoscopic trainer and box trainer with eye patch. Time to completion is recorded.

    Device: Computerized Laparoscopic Trainer · Device: Box trainer with eye patch

Interventions

  • DeviceComputerized Laparoscopic Trainer

    Gold standard laparoscopic trainer using simulated computerized equipment.

  • DeviceBox trainer with eye patch

    Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch

05

What researchers measure

Primary outcomes

  1. Time to completion of laparoscopic tasks.

    Time frame: 5 minutes

06

Study locations

2 sites
  • University Of Nottingham
    Derby, DE22 3NE, United Kingdom
  • The Medical School, University of Nottingham, Royal Derby Hospital.
    Derby, DE22, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03407235
Lead sponsor
University of Nottingham
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Dec 11, 2017
Primary completion
May 1, 2018
Completion
Aug 1, 2018
Last update
Oct 15, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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